Market scenario —
Analytical testing is one of the critical elements in the drug development process. In the pharmaceutical analysis, analytical assay methods are included in the compendial monographs with the aim to characterize the quality of bulk drug materials by setting limits of their active ingredient content.
Global pharmaceutical analytical testing outsourcing market is expected to grow significantly over the forecast period. It is anticipated that the market held a valuation of USD 5080 million in 2017 and is projected to grow at a CAGR of 7.45% over the forecast period.
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Intense competition among pharmaceutical companies has placed pressure on analytical testing providers to generate quality results. Analytical testing helps in improving productivity, characterize biologics and biosimilars, optimize and monitor processes and provide real-time product quality control. One of the most prominent reasons companies outsource analytical testing services is to access expertise, experience and expensive analytical equipment not available in-house.
Various other factors such as increasing research and development investments, increasing awareness about product quality, and safety and changing regulations for in vivo and in vitro tests are also expected to propel the growth of the market.
However, lack of awareness, and quality approvals and regulatory audits conducted in outsourcing laboratories can hinder the market growth over the forecast period.
Some of the key players in the global Pharmaceutical Analytical Testing Outsourcing market are SGS SA, Toxikon, Inc, Eurofins Scientific, Pace Analytical Services LLC, Intertek Group plc, Pharmaceutical Product Development, LLC, Exova Group plc, Boston Analytical, Charles River Laboratories International, Inc, West Pharmaceutical Services, Merck KGaA, WuXi AppTec, Source BioScience and others.
The Global pharmaceutical analytical testing outsourcing market is segmented based on product type, services, end user and region.
The Global market for pharmaceutical analytical testing outsourcing, by product type is segmented into raw materials, finished products and active pharmaceutical ingredients.
The market, by services, is segmented into bioanalytical testing, method development & validation, stability testing, and others. The bioanalytical testing segment is further classified as clinical and non-clinical. The method development & validation segment is further classified as extractable & leachable, impurity method, technical consulting and others. The stability testing is further classified as drug substance, stability indicating method validation, accelerated stability testing, photostability testing and others.
Based on end user, the market is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations and others.
In the current scope of the study, the above-mentioned segments are covered into the four global regions, namely the Americas, Europe, Asia-Pacific and the Middle East & African region.
The pharmaceutical analytical testing outsourcing market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.
The European pharmaceutical analytical testing outsourcing market has been segmented into Western Europe and Eastern Europe. Western Europe has been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe. The pharmaceutical analytical testing outsourcing market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The pharmaceutical analytical testing outsourcing market in the Middle East & Africa has been segmented into the Middle East and Africa.
Regional Market Summary
The Americas dominated the global market for pharmaceutical analytical testing outsourcing owing to presence of major market players and developed economies like US and Canada within the region. In 2018, Pharmaceutical Product Development, LLC expanded its GMP-compliant, analytical laboratory in Middleton, Wisconsin, USA. The new 32,000-square-foot lab, complements the company’s existing biologics capacity and was constructed for the stability and quality control testing of large-molecule drug products.
In 2017, it was estimated that Europe stood second in the global pharmaceutical analytical testing outsourcing market. This can be attributed to the rising research and development investments. For instance, in 2018, Almac Group announced that it will invest USD 493,000 in additional nuclear magnetic resonance instrumentation at its headquarters in Craigavon, UK.
Asia Pacific was projected to be the fastest growing region in 2017. Factors such as growing healthcare sector, increasing penetration of the market players within the region, and increasing government’s support for foreign investments drives the regional markets of the Asia Pacific region.
On the other hand, the Middle East and Africa held least share in the global pharmaceutical analytical testing outsourcing market due to the low per capita income, especially within the African region.
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